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Androgel Side Effects

Common Androgel Side Effects

The most commonly reported Androgel side effects (click to view or check a box to report):

Blood Testosterone Decreased (608)
Asthenia (213)
Fatigue (201)
Blood Testosterone Increased (113)
Prostatic Specific Antigen Increased (106)
Incorrect Dose Administered (102)
Acne (101)
Blood Testosterone Abnormal (95)
Weight Increased (93)
Libido Decreased (93)
Alopecia (87)
Erectile Dysfunction (82)
Arthralgia (77)
Insomnia (73)
Dyspnoea (73)
Rash (71)
Pain (70)
Hair Growth Abnormal (70)
Headache (66)
Therapeutic Response Unexpected (66)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Androgel Side Effects Reported to FDA

The following Androgel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Androgel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Pulmonary Embolism, Deep Vein Thrombosis
on Mar 11, 2014 Male from US , 62 years of age, weighting 205.0 lb, was diagnosed with and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: pulmonary embolism, deep vein thrombosis. Androgel dosage: 2 Pumps Ea. Arm Once Daily Applied To A Surface, Usually The Skin. Patient was hospitalized.

Cerebral Thrombosis, Brain Injury
Patient was taking Androgel. Patient felt the following Androgel side effects: cerebral thrombosis, brain injury on Mar 07, 2014 from US Additional patient health information: Male , 41 years of age, weighting 253.0 lb, was diagnosed with and. Androgel dosage: N/A. Patient was hospitalized and became disabled.

Pulmonary Embolism, Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
Adverse event was reported on Mar 07, 2014 by a Male taking Androgel (Dosage: N/A) was diagnosed with and. Location: US , 56 years of age, After Androgel was administered, patient encountered several Androgel side effects: pulmonary embolism, thrombosis, impaired work ability, pain, anxiety, physical disability, emotional distress. Patient was hospitalized.

Cerebrovascular Accident, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
on Mar 07, 2014 Male from US , 53 years of age, was diagnosed with and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: cerebrovascular accident, deep vein thrombosis, impaired work ability, pain, anxiety, physical disability, emotional distress. Androgel dosage: N/A. Patient was hospitalized.


Pneumonia, Atrial Fibrillation, Dyspnoea, Pallor
on Mar 07, 2014 Male from US , 64 years of age, weighting 273.2 lb, was diagnosed with and was treated with Androgel. Patient felt the following Androgel side effects: pneumonia, atrial fibrillation, dyspnoea, pallor. Androgel dosage: N/A.
Multiple prescriptions taken:
  • Cholecalciferol
  • Omeprazole
  • Simvastatin
  • Sildenafil Fibrate
Patient was hospitalized.

Myocardial Infarction, Physical Disability, Emotional Distress, Pain, Loss Of Employment
Patient was taking Androgel. After Androgel was administered, patient encountered several Androgel side effects: myocardial infarction, physical disability, emotional distress, pain, loss of employment on Mar 07, 2014 from US Additional patient health information: Patient , 45 years of age, was diagnosed with and. Androgel dosage: N/A.

Pain, Anxiety, Physical Disability, Emotional Distress, Pulmonary Embolism, Impaired Work Ability
Adverse event was reported on Mar 07, 2014 by a Male taking Androgel (Dosage: Multiple Doses) was diagnosed with and. Location: US , 54 years of age, Directly after, patient experienced the unwanted or unexpected Androgel side effects: pain, anxiety, physical disability, emotional distress, pulmonary embolism, impaired work ability. Patient was hospitalized.

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
on Mar 07, 2014 Male from US , 56 years of age, was diagnosed with and was treated with Androgel. Patient felt the following Androgel side effects: physical disability, emotional distress, impaired work ability, pain, anxiety, deep vein thrombosis, pulmonary embolism. Androgel dosage: N/A. Patient was hospitalized.

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
on Mar 07, 2014 Male from US , 42 years of age, was diagnosed with and was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: physical disability, emotional distress, impaired work ability, pain, anxiety, deep vein thrombosis, pulmonary embolism. Androgel dosage: Multiple Doses. Patient was hospitalized.

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
Patient was taking Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: physical disability, emotional distress, impaired work ability, pain, anxiety, deep vein thrombosis, pulmonary embolism on Mar 07, 2014 from US Additional patient health information: Male , 54 years of age, was diagnosed with and. Androgel dosage: N/A. Patient was hospitalized.

Cerebrovascular Accident, Physical Disability, Emotional Distress, Pain, Loss Of Employment, Pulmonary Embolism
Adverse event was reported on Mar 07, 2014 by a Male taking Androgel (Dosage: N/A) was diagnosed with and. Location: US , 74 years of age, Patient felt the following Androgel side effects: cerebrovascular accident, physical disability, emotional distress, pain, loss of employment, pulmonary embolism. Patient was hospitalized.

Pulmonary Embolism, Thrombosis, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
on Mar 07, 2014 Male from US , 39 years of age, was diagnosed with and was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: pulmonary embolism, thrombosis, physical disability, emotional distress, impaired work ability, pain, anxiety. Androgel dosage: N/A. Patient was hospitalized.

Cerebrovascular Accident, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
on Mar 07, 2014 Male from US , 57 years of age, was diagnosed with and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: cerebrovascular accident, physical disability, emotional distress, impaired work ability, pain, anxiety. Androgel dosage: N/A. Patient was hospitalized.

Cerebrovascular Accident, Hemiplegia
Patient was taking Androgel. Patient felt the following Androgel side effects: cerebrovascular accident, hemiplegia on Mar 06, 2014 from US Additional patient health information: Male , 58 years of age, . Androgel dosage: N/A. Patient was hospitalized.

Myocardial Infarction
Adverse event was reported on Mar 05, 2014 by a Male taking Androgel (Dosage: N/A) was diagnosed with and. Location: US , 60 years of age, weighting 200.6 lb, After Androgel was administered, patient encountered several Androgel side effects: myocardial infarction.
Multiple concurrent drugs taken:
  • Duloxetine
  • Clonazepam
  • Fish Oil
Patient was hospitalized.

Physical Disability, Pulmonary Embolism, Emotional Distress, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety
on Mar 06, 2014 Male from US , 60 years of age, was diagnosed with and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: physical disability, pulmonary embolism, emotional distress, deep vein thrombosis, impaired work ability, pain, anxiety. Androgel dosage: Multiple Doses. Patient was hospitalized.

Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
on Mar 06, 2014 Male from US , 57 years of age, was diagnosed with and was treated with Androgel. Patient felt the following Androgel side effects: physical disability, pulmonary embolism, emotional distress, impaired work ability, pain, anxiety. Androgel dosage: Multiple Doses. Patient was hospitalized.

Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
Patient was taking Androgel. After Androgel was administered, patient encountered several Androgel side effects: physical disability, pulmonary embolism, emotional distress, impaired work ability, pain, anxiety on Mar 06, 2014 from US Additional patient health information: Male , 54 years of age, was diagnosed with and. Androgel dosage: Multiple Doses. Patient was hospitalized.

Physical Disability, Deep Vein Thrombosis, Emotional Distress, Impaired Work Ability, Pain, Anxiety
Adverse event was reported on Mar 06, 2014 by a Male taking Androgel (Dosage: Multiple Doses) was diagnosed with and. Location: US , 46 years of age, Directly after, patient experienced the unwanted or unexpected Androgel side effects: physical disability, deep vein thrombosis, emotional distress, impaired work ability, pain, anxiety. Patient was hospitalized.

Pulmonary Embolism
on Mar 04, 2014 Male from US , 50 years of age, was treated with Androgel. Patient felt the following Androgel side effects: pulmonary embolism. Androgel dosage: 4 Pumps Daily; Applied To A Surface, Usually The Skin. Patient was hospitalized and became disabled.

Chest Pain, Pulmonary Thrombosis
on Mar 04, 2014 Male from US , 54 years of age, was treated with Androgel 1 %. After Androgel was administered, patient encountered several Androgel side effects: chest pain, pulmonary thrombosis. Androgel 1 % dosage: 2 Pumps Per Day Applied To A Surface, Usually The Skin. Patient was hospitalized and became disabled.

Prostatic Specific Antigen Increased, Biopsy Prostate Abnormal
Patient was taking Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: prostatic specific antigen increased, biopsy prostate abnormal on Feb 28, 2014 from US Additional patient health information: Male , 62 years of age, weighting 195.0 lb, was diagnosed with and. Androgel dosage: N/A.

Tendon Rupture, Bundle Branch Block Right, Pain In Extremity, Limb Injury
Adverse event was reported on Mar 05, 2014 by a Male taking Androgel (Dosage: 4 Pumps) was diagnosed with and. Location: US , 52 years of age, weighting 190.2 lb, Patient felt the following Androgel side effects: tendon rupture, bundle branch block right, pain in extremity, limb injury.
Multiple prescriptions taken:
  • Amlodipine
  • Simvastatin
  • Sumatriptan
  • Multivitamin
  • Fish Oil
  • Baby Aspirin


Arterial Occlusive Disease
on Mar 04, 2014 Male from US , 75 years of age, was treated with Androgel. After Androgel was administered, patient encountered several Androgel side effects: arterial occlusive disease. Androgel dosage: N/A.

Abdominal Pain, Gallbladder Perforation, Appendicitis, Cholecystitis, Abdominal Infection, Unevaluable Event, Musculoskeletal Pain, Pain In Extremity
on Mar 04, 2014 Male from COUNTRY NOT SPECIFIED , 40 years of age, weighting 269.3 lb, was diagnosed with and was treated with Androgel. Directly after, patient experienced the unwanted or unexpected Androgel side effects: abdominal pain, gallbladder perforation, appendicitis, cholecystitis, abdominal infection, unevaluable event, musculoskeletal pain, pain in extremity. Androgel dosage: 2 Pumps Daily.
Associated medications used:
  • Testosterone
  • Amitriptyline
  • Elavil
  • Robaxin
  • Xanax
  • Effexor
  • Wellbutrin (Took 15 Pills)
  • Buprenorphine
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Androgel Side Effects

    Did You Have a Androgel Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Androgel for You?

    Exceeded Expectations
    Effective
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    Safety Alerts, Active Ingredients, Usage Information

    Alternative ANDROGEL Names:TESTOSTER

    Active Ingredient: TESTOSTER

    Androgel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2967

    Androgel safety alerts: 2009

    Reported deaths: 32

    Reported hospitalizations: 249

    Testosterone gel products (AndroGel 1% and Testim 1% )

    Audience: Urological and Endocrinological healthcare professionals, pediatricians 

    [Posted 05/07/2009] FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the productsâ?? labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

    [May 07, 2009 - News Release - FDA]

    [May 07, 2009 - Testosterone Gel Safety Information Page - FDA]

    Latest Androgel clinical trials